In needle devices, it is known to mount a needle on a frame that telescopes inside a sheath, the sheath extending around the needle to protect the needle except when in use. In such a device, the sheath and needle are moved from a needle-sheathed, nonuseful position, to a needle-unsheathed position in which the needle extends out through the aperture, as shown in, e.g., U.S. Pat. No. 4,425,120. However, the disadvantage of such a device is that there is no provision to prevent the needle from being reused. Even if it is moved back into said sheathed (protected) position, there is nothing that prevents it from being pushed out again where it can either intentionally or unintentionally inject a person. That is, the detent mechanism for keeping the needle sheathed is not a permanent disabling feature. This is understandable, since the device has to be unsheathed to be used. However, it means that no permanent disabling of the needle can be done after its first use.
Current methods of using needles, e.g., in drawing blood from or injecting drugs into a mammalian body, run substantial risks of contamination if a needle can be reused or restuck into another mammal, after having been used once. For this reason, standard health practice is to destroy each needle after one use. However, there is always the possibility, for standard syringe-type devices that do not provide adequate sheathing, that the needle will be stuck accidentally into another body before or while it is being destroyed. Furthermore, the snapping of a used needle, one method used to break them, can produce an aerosol that can be contaminating.
Because of the above problems, packaging has been provided to ensure that the needle is used only once and is not reusable when closed into its container. Thus, devices of the type shown in U.S. Pat. No. 4,664,259, allow a needle to pivot relative to a package through a slot, and when the package is pivoted back over the needle, the needle is captured by a hook to permanently prevent its reuse. Such a design, however, has several drawbacks. Most important is the fact that the sheathed position of the needle within the housing is the same whether or not the disabling mechanism is in place--that is, an operator cannot tell the status simply by looking at the housing. What has been needed, therefore, prior to this invention is a needle housing and locking mechanism for permanent disabling, that is operable using visual positioning that is unique to the needle status.
Yet another difficulty with devices such as are shown in U.S. Pat. No. 4,425,120 is that the relative movement of needle and housing, to expose or withdraw the needle, is a fairly complicated two-handed operation requiring both a twisting and a translation. There has been a need prior to this invention to provide needle housing devices that are not only protective, but can be operated with one hand.
Yet another problem with conventional phlebotomy devices is that they do not combine the collection, phase separation and automated dispensing of the serum all in one integrated device.